【摘要】 目的以上市头孢氨苄普通胶囊为参比制剂,考察24h给药一次的头孢氨苄缓释片beagle犬体内药动学。方法 Beagle犬单剂量口服受试制剂和参比制剂,采用HPLC法进行生物等效性评价。结果方法学研究结果显示线性范围0.5～50μg/mL,高中低相对回收率均大于80%,日内日间精密度均小于15%,最低定量限0.5μg/mL。参比制剂与受试制剂药动学参数分别为:Cmax为(35.02±8.67)和(22.8±74.11)μg/mL,AUC0-∞为(164.59±17.79)和(201.15±89.87)μg/(h·mL),Tmax为(2.1±1.0)和(4.2±0.4)h。受试制剂相对生物利用度为(104.4±21.4)%。结论两种制剂生物等效。更多还原

【Abstract】 Objective The pharmacokinetic of cefalexin sustained-release tablet in beagle dogs were performed with cefalexin capsule as the control.Methods Pharmacokinetic parameters were evaluated by HPLC method after a single oral dose of the referenced formulation and the tested formulation.Results The linearity was obtained over the concentration range of 0.5～50μg/mL for cefalexin.The relative recovery of cefalexin at high,medium and low concentrations were ≥80%.Both inter-and intra-day RSD were ≤15% for cefalexin.The limit of detection for cefalexin was 0.5μg/mL.The pharmacokinetic parameters of cefalexin capsules referenced formulation and the tested formulation were shown as follows: Cmax were(35.02±8.67) and(22.8±74.11)μg/mL,AUC0-∞ were(164.59±17.79) and(201.15±89.87)μg/(h·mL),Tmax were(2.1±1.0) and(4.2±0.4)h.The relative bioavailability of tested formulation was(104.4±21.4)%.Conclusion The tested formu1ation is bioequivalent with the referenced formulation.更多还原